Prospect: information for the user

Imigran 10 mg nasal spray solution

Sumatriptán

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What Imigran is and for what it is used

2.What you need to know before starting to use Imigran

3.How to use Imigran

4.Possible adverse effects

5.Storage of Imigran

6.Contents of the package and additional information

Each Imigran 10 mg inhaler contains a single dose of sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists).

Imigran 10 mg is used to treat migraine headache.

The symptoms of migraine may be caused by a temporary dilation of the blood vessels in the head. It is believed that Imigran 10 mg reduces the dilation of these blood vessels. This in turn helps to relieve headache pain and alleviate other symptoms of a migraine attack, such as nausea or vomiting and sensitivity to light and sound.

Do not use Imigran 10 mg

• if you are allergicto sumatriptan or to any of the other ingredients of this medicine (listed in section 6)
• if you have heart problemssuch as narrowing of the arteries(ischaemic heart disease)or chest pain(angina), or have had a heart attack
• if you have circulation problems in your legsthat cause pain, such as cramp when walking(peripheral vascular disease)
• if you have had a strokeor a mini-stroke(also known as transient ischaemic attack or TIA)
• if you have high blood pressure. You can use Imigran 10 mg if your blood pressure is slightly raised and you are being treated
• if you have severe liver disease
• with other migraine medicines,including those containing ergotamine, or similar medicines such as methysergide or any triptan/5-HT1 receptor agonist(medicines also used to treat migraine)
• with antidepressants called MAOIs(monoamine oxidase inhibitors),or if you have taken these medicines in the last 2 weeks.

If any of these apply to you:

?Inform your doctor, and do not use Imigran 10 mg.

Be careful with Imigran 10 mg

Consult your doctor or pharmacist before starting to use Imigran 10 mg.

If you have any extra risk factors

• if you smoke heavilyor are usingnicotine replacement therapy, and especially
• if you are a man over 40 years old,or
• if you are a woman who has started the menopause.

In very rare cases, people have developed serious heart problems after using Imigran 10 mg, even though they had no signs of heart disease beforehand. If any of the above points apply to you, it may mean you have a higher risk of developing heart disease, so:

?Inform your doctor to check your heart functionbefore Imigran 10 mg is prescribed to you.

If you have a history of fits(seizures)

Or if you have other conditions that may make you more likely to have fits – for example, a head injury or alcoholism:

?Inform your doctor to be monitored more closely..

If you have liver or kidney disease

?Inform your doctor to be monitored more closely.

If you are allergic to sulphonamide antibiotics

If you are, you may also be allergic to Imigran 10 mg. If you know you are allergic to antibiotics, but are not sure if it is a sulphonamide:

?Inform your doctor or pharmacist before using Imigran 10 mg.

If you are taking antidepressants called SSRIs(Selective Serotonin Reuptake Inhibitors)orSNRIs(Serotonin and Noradrenaline Reuptake Inhibitors)

?Inform your doctor or pharmacist before using Imigran 10 mg. See also,Other medicines and Imigran 10 mg.

If you use Imigran 10 mg frequently.

Frequent use of Imigran 10 mg may make your headaches worse.

?Inform your doctor if this happens to you.Your doctor may recommend that you stop using Imigran 10 mg.

If you feel pain or tightness in the chest after using Imigran 10 mg

These effects may intensify but usually pass quickly. If they do not pass quickly or become more severe:

?Get medical help immediately.See section 4 of this leaflet for more information about these possible side effects.

Other medicines and Imigran 10 mg

Inform your doctor or pharmacist if you are taking,have taken recently or may need to take any other medicine. This includes any herbal or over-the-counter medicines.

Some medicines should not be taken with Imigran 10 mg and others may cause side effects if taken with Imigran 10 mg.Inform your doctor if you are taking other medicines,such as:

• Ergotamine, whichis also used to treat migraine,or similar medicines like methysergide (see section 2No use Imigran 10 mg). Do not use Imigran 10 mg at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran 10 mg. Do not take any other medicine that contains ergotamine or similar compounds until at least 6 hours after using Imigran 10 mg.
• Other triptans/5-HT1 receptor agonists(such as naratriptan, rizatriptan, zolmitriptan),also used to treatmigraine,(see section 2No use Imigran 10 mg). Do not use Imigran 10 mg at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran 10 mg.Do not take another triptan/5-HT1 receptor agonist at least 24 hours after using Imigran 10 mg.
• SSRIs(Selective Serotonin Reuptake Inhibitors)orSNRIs(Serotonin and Noradrenaline Reuptake Inhibitors)used to treatdepression. The use of Imigran 10 mg with these medicines may cause serotonin syndrome(a group of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, chills, increased heart rate and agitation). Inform your doctor immediately if you are affected in this way.
• MAOIs(monoamine oxidase inhibitors)used to treatdepression.Do not use Imigran 10 mg if you have taken these medicines in the last 2 weeks.
• St John's Wort(Hypericum perforatum). It is more likely that you will experience side effects if you take herbal remedies that contain St John's Wortwhile using Imigran 10 mg.

Pregnancy and breastfeeding

Inform your doctor or pharmacist before using any medicine.

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine. There is limited information on the safety of Imigran 10 mg in pregnant women, although so far there is no evidence that it increases the risk of birth defects. Your doctor will assess with you whether you should or should not use Imigran 10 mg while pregnant.
• Do not breastfeed your baby for12 hours after taking Imigran 10 mg. If you express milk during this time, discard the milk and do not give it to your baby.

Driving and using machines

The symptoms of migraine or the medicine may make you feel drowsy.Do not drive or operate machines if this happens.

Only use Imigran 10 mg after your migraine headache has started.

Do not use Imigran 10 mg to prevent a migraine attack.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

There is a step-by-step guidefor the use of the sprayer at the end of the prospectus (see section 6).

How much to administer

Adults 18 years and older

• The usual dose for adults between 18 and 65 years of ageis one spray of Imigran 20 mg in one nostril.

For some people,one spray ofImigran 10mg in one nostril may be sufficient.

Do not use more than two sprays in 24 hours.

Adolescents between 12 and 17 years

• The usual dose for adolescents between 12 and 17 yearsis one spray of Imigran 10mgin one nostril.

Children under 12 years

• Imigran 10 mg is not recommended forchildren under 12 years.

Seniors (65 years and older)

• Imigran 10 mg is not recommended forpeople 65 years and older.

When to use Imigran 10 mg

• It is best to use Imigran 10 mg as soon as you feel the migraine starting,although you can use it at any time during the attack.

If symptoms return

• You can use a second spray of Imigran 10 mg after 2 hours, butdo not use more than two sprays in 24 hours.

If the first spray has not had an effect

• Do not use a second spray,or any other preparation ofImigran for the same attack.

If Imigran 10 mg does not provide relief:

?Consult your doctor or pharmacist for advice.

If you use more Imigran 10 mg than you should

• Do not use more than two sprays of Imigran 10 mg in 24 hours

Excessive use of Imigran 10 mg may harm you. If you have used more than two sprays in 24 hours:

?Contact your doctor for advice.

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some of these symptoms may be caused by the migraine itself.

The side effects reported in adults have also been observed in adolescents. These include very rare cases of heart attacks.

Allergic reactions: seek medical help immediately

The following side effects have occurred in a very small number of people and their exact frequency is unknown.

• The signs of an allergic reaction include rash, hives (itching and rash); wheezing (chest wheezing); swollen eyelids, face, or lips, complete collapse.

If you notice any of these symptoms shortly after using Imigran 10 mg:

?Do not use it again.Immediately contact your doctor.

Very common side effects

(affect more than1 in 10people)

• Unpleasant taste.

Common side effects

(affect up to1 in 10people)

• Pain, heaviness, pressure, oppression, or pain in the chest, throat, or other parts of the body, or unusual sensations, including numbness, tingling, and heat or cold. These effects can be intense, but generally disappear quickly.

If these effects persist or worsen(especially chest pain):

?Seek urgent medical help. In a reduced number of people, these symptoms may be caused by heart attacks.

Other common side effects include:

• Irritation or sensation of burning in the nose or throat, nasal bleeding.
• Nausea or vomiting, although this may be due to the migraine itself.
• Tiredness or drowsiness.
• Dizziness, feeling of weakness or hot flushes.
• Temporary increase in blood pressure.
• Difficulty breathing.
• Muscle pain.

Rare side effects

(affect up to1 in 10,000people)

• Liver function abnormalities. Inform your doctor or nurse that you are taking Imigran 10 mg, if you are to have a blood test to check liver function.

Some patients may experience any of the following side effects, but the frequency with which they occur is unknown

• Seizures/attacks, tremors, muscle spasms, neck stiffness.
• Visual disturbances such as blinking, reduced vision, double vision, loss of vision, and in some cases, even permanent defects (although these may be due to the migraine attack itself).
• Cardiac problems, in which the heart may beat faster, slower, or with changes in rhythm, chest pain (angina) or heart attack.
• Pallor, blue skin, and/or pain in the fingers of the hands, toes, ears, nose, or jaw in response to cold or stress (Raynaud's phenomenon).
• Feeling of weakness (may decrease blood pressure).
• Pain in the lower left abdomen and bloody diarrhea (ischemic colitis).
• Diarrhea.
• If you have had a recent injury or if you have inflammation (such as rheumatism or colon inflammation), you may experience pain or worsening of pain in the injured or inflamed area.
• Joint pain.
• Anxiety.
• Difficulty swallowing.
• Excessive sweating.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Keep this medication in the sealed outer packaging (blister) to protect it from light.

Do not store at a temperature above 86°F and do not freeze.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Imigran 10 mg

The active ingredientissumatriptan (10mg).

The other componentsaredihydrogen phosphate of potassium, sodium dihydrate phosphate anhydrous, sulfuric acid, sodium hydroxide, and purified water.

Appearance of the product and contents of the package

This medicine is contained in a preloaded spray device and contains sumatriptan in 0.1ml of yellow-colored solution.

Imigran 10 mg is packaged in a box containing single-dose nasal spray devices in sealed blister packs. They are available in packaging with 1, 2, or 6 preloaded nasal spray devices, although not all package sizes are available in your country. Each device contains a dose of Imigran 10 mg.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Phone: +34 900 202 700

[email protected]

Responsible manufacturer:

GlaxoSmithKline Manufacturing S.p.A.

Strada Provinciale Asolana, 90

43056 San Polo di Torrile

Parma

Italy

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

• Imigran nasal spray:Austria, Denmark, Finland, Germany, Italy, Netherlands, Spain, Sweden, and United Kingdom (Northern Ireland).
• Imitrex nasal spray:Belgium and Luxembourg.

Last review date of this leaflet:October 2021.

Follow the step-by-step guide for Imigran 10 mg

Do not open the blister pack until you are ready to use the spray device.Each spray device is sealed in a blister pack to keep it safe and clean. If you carry a spray device without the blister pack, or in an open blister pack, it may not work properly when you need it.

Each spray device contains only one dose of Imigran 10 mg.

Do not press the plunger too soon or you will lose the dose.

Imigran 10 mg consists of three parts:

How to use the nasal spray device

1. Remove the nasal spray device from thealveolar packaging (blister pack) only before its immediate use.
2. Get into a comfortable position, preferably sitting.
3. If you feel that your nose is blocked or you are congested, blow your nose.
4. Hold the nasal spray devicegently with your fingers and thumb as shown in Figure A.

Do not press the blue plunger yet.

1. Close one nostrilby pressing firmly with one finger. It does not matter which nostril you choose.

1. Insert the spray device into the other nostril,as far as is comfortable – over 1 cm or half an inch (Figure B).

Exhale gently through the mouth.

Keep the head upright and close the mouth.

1. Start taking a gentle breath through the nose.

While taking the breath:

Press the blue plunger firmly with your thumb.

The plunger may be a bit stuck and you may hear a click. Hold your breath while inhaling (Figure C).

1. Remove the nasal spray deviceand remove the finger from the side of the nose.

Keep the head upright for 10-20 seconds,breathing gently through the nose and exhaling through the mouth. This helps the medicine stay in the nose.

You may notice that your nose is wet inside and you may experience a characteristic taste after using the nasal spray device – this is normal and will pass soon.

1. Your nasal spray device is now empty.Dispose of it safely and hygienically.

For more detailed and up-to-date information on this medicine, visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/